Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Derma-Smoothe/FS
Product Details
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 118.28 mL Bottle Label
NDC 68791-101-04
Rx only
Derma-Smoothe/FS**®**
Fluocinolone Acetonide
0.01% Topical Oil
(BODY OIL)
FOR TOPICAL USE ONLY
NOT FOR ORAL, OPHTHALMIC,
or INTRAVAGINAL USE
SHAKE WELL BEFORE USE
Net Contents 118.28 mL
(4 fL. oz.)
ROYAL
PHARMACEUTICALS**®**
RECENT MAJOR CHANGES SECTION
RECENT MAJOR CHANGES
Indication and Usage, Pediatric Patients with Atopic Dermatitis (1.2) 11/2007
CLINICAL PHARMACOLOGY SECTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Like other topical corticosteroids, fluocinolone acetonide has anti- inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
12.3 Pharmacokinetics
Topical corticosteroids can be absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the product formulation and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may increase percutaneous absorption.
The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids may be necessary due to the fact that circulating levels are often below the level of detection. Once absorbed through the skin, topical corticosteroids are metabolized primarily in the liver, and are then excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile.
Derma-Smoothe/FS® is in the low to medium range of potency as compared with other topical corticosteroids in vasoconstrictor studies.
DOSAGE FORMS & STRENGTHS SECTION
Highlight: Derma-Smoothe/FS® (fluocinolone acetonide) Topical Oil, 0.01% (Body Oil) is supplied in bottles containing 4 fluid ounces. (3)
3 DOSAGE FORMS AND STRENGTHS
Derma-Smoothe/FS® (fluocinolone acetonide), Topical Oil, 0.01% (Body Oil) is supplied in bottles containing 4 fluid ounces.
CONTRAINDICATIONS SECTION
Highlight: None (4)
4 CONTRAINDICATIONS
None.
USE IN SPECIFIC POPULATIONS SECTION
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Category C: Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.
There are no adequate and well-controlled studies in pregnant women on teratogenic effects from Derma-Smoothe/FS®. Therefore, Derma-Smoothe/FS® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
8.3 Nursing Mothers
Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk.
Because many drugs are excreted in human milk, caution should be exercised when Derma-Smoothe/FS® is administered to a nursing woman.
8.4 Pediatric Use
8.4.1 Systemic Adverse Reactions in Pediatric Patients
HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and subnormal response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Because of a higher ratio of skin surface area to body mass, children are at a greater risk for systemic adverse reactions than are adults when treated with topical corticosteroids. [See Warnings and Precautions (5.1)]
8.4.2 Evaluation in Peanut-Sensitive Pediatric Subjects
A clinical study was conducted to assess the safety of Derma-Smoothe/FS®, which contains refined peanut oil, on subjects with known peanut allergies. The study enrolled 13 subjects with atopic dermatitis, 6 to 17 years of age. Of the 13 subjects, 9 were Radioallergosorbent Test (RAST) positive to peanuts and 4 had no peanut sensitivity (controls). The study evaluated the subjects' responses to both prick test and patch test utilizing peanut oil NF, Derma- Smoothe/FS® and histamine/saline controls. Subjects were also treated with Derma-Smoothe/FS® twice daily for 7 days. Prick test and patch test results for all 13 patients were negative to Derma-Smoothe/FS® and the refined peanut oil. One of the 9 peanut-sensitive patients experienced an exacerbation of atopic dermatitis after 5 days of Derma-Smoothe/FS®. The bulk peanut oil NF, used in Derma-Smoothe/FS® is heated at 475°F for at least 15 minutes, which should provide for adequate decomposition of allergenic proteins. [See Description (11)]
8.4.3 Evaluation in Pediatric Subjects 2 to 6 years old
Open-label safety studies were conducted on 33 children (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe stable atopic dermatitis. Subjects were treated with Derma-Smoothe/FS® twice daily for 4 weeks. Baseline body surface area involvement was 50% to 75% in 15 subjects and greater than 75% in 18 subjects. Morning pre-stimulation cortisol and post-ACTH stimulation cortisol levels were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment. At the end of treatment, 4 out of 18 subjects aged 2 to 5 years showed low pre-stimulation cortisol levels (3.2 to 6.6 µg/dL; normal: cortisol > 7µg/dL) but all had normal responses to 0.25 mg of ACTH stimulation (cortisol > 18 µg/dL).
8.4.4 Evaluation in Pediatric Subjects 3 months to 2 years old
An open-label safety study was conducted in 29 children (7 subjects ages 3 to 6 months, 7 subjects ages > 6 to 12 months and 15 subjects ages > 12 months to 2 years of age) to assess the HPA axis by ACTH stimulation testing following use of Derma-Smoothe/FS® twice daily for 4 weeks. All subjects had moderate to severe atopic dermatitis with disease involvement on at least 20% body surface area. Baseline body surface area involvement was 50% to 75% in 11 subjects and greater than 75% in 7 subjects. Morning pre-stimulation and post-ACTH stimulation cortisol levels were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment. All subjects had normal responses to 0.125 mg of ACTH stimulation (cortisol > 18 µg/dL).
OVERDOSAGE SECTION
10 OVERDOSAGE
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects, including under conditions of normal use. [See Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].
HOW SUPPLIED SECTION
16 HOW SUPPLIED / STORAGE AND HANDLING
Derma-Smoothe/FS® is supplied in bottles containing 4 fluid ounces. It is labeled as Body Oil (NDC # 68791-101-04).
Storage: Store at 25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].
SPL UNCLASSIFIED SECTION
Manufactured by:
Hill Dermaceuticals, Inc.®
Sanford, FL 32773
1.800.344.5707
For: Royal Pharmaceuticals, Inc
Manasquan, NJ 08736
1.800.510.3401
Rev. CODE 171A240-1
Date: 10/2013